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A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL


- To determine the response rate in patients with previously untreated B-cell chronic
lymphocytic leukemia treated with alemtuzumab and rituximab.

- To evaluate the toxicity of alemtuzumab and rituximab in these patients.

OUTLINE: Patients receive alemtuzumab subcutaneously on days 1, 3, and 5 in weeks 1-18 and
rituximab IV on day 1 in weeks 3, 5, 7, 9, 11, 13, 15, and 17 in the absence of disease
progression or unacceptable toxicity.

Peripheral blood and bone marrow samples are collected periodically for laboratory biomarker
studies. Samples are analyzed for surface markers (e.g., CD3, CD4, CD8, CD10, CD19, CD20,
CD25, CD38, CD52, Zap-70) and IgVH by PCR, flow cytometry, and FISH. Samples are also
analyzed for alemtuzumab and anti-alemtuzumab antibody levels by flow cytometry.

After completion of study treatment, patients are followed periodically for 5 years.

Inclusion Criteria


- Diagnosis of B-cell chronic lymphocytic leukemia (CLL)*, as defined by the following

- Peripheral blood absolute lymphocyte count > 5,000/mm³

- Small- to moderate-size lymphocytes with < 55% prolymphocytes, atypical
lymphocytes, or lymphoblasts

- Phenotypically characterized B-CLL expressing CD20 and CD52, as defined by the

- Predominant population of cells share B-cell antigens with CD-5 in the
absence of other pan-T-cell markers (e.g., CD-3, CD-2)

- B-cell expresses either lambda or kappa light chains

- Surface immunoglobulin with low-cell surface density expression NOTE:
*Presence of splenomegaly, hepatomegaly, or lymphadenopathy are not
required for the diagnosis of CLL

- Requires therapy, as indicated by ≥ 1 of the following criteria:

- Unintentional weight loss > 10% within the past 6 months

- Extreme fatigue (i.e., ECOG performance status 2)

- Fevers > 100.5°F for 2 weeks without evidence of infection

- Night sweats without evidence of infection

- Evidence of progressive marrow failure as manifested by the development of or
worsening of anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelet
count < 100,000/mm³)

- Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly

- Massive nodes/clusters (> 5 cm), progressive symptomatic adenopathy, or
adenopathy resulting in end-organ damage

- Progressive lymphocytosis with an increase of > 50% over 2 months or an
anticipated doubling time < 6 months

- Marked hypogammaglobulinemia or the development of a monoclonal protein in the
absence of any of the above criteria for active disease is not sufficient for


- ECOG performance status 0-2

- ANC ≥ 1,000/mm³*

- Platelet count ≥ 50,000/mm³*

- Hemoglobin ≥ 10 g/dL*

- Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance > 40 mL/min

- Bilirubin < 2 mg/dL

- AST and ALT ≤ 2 times normal (unless secondary to tumor infiltration/lymphadenopathy)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No active autoimmune anemia or thrombocytopenia

- No active infection requiring oral or intravenous antibiotics

- No second malignancy, other than basal cell carcinoma of the skin or in situ
carcinoma of the cervix, unless curatively treated ≥ 2 years ago NOTE: *If cytopenias
are due to degree of bone marrow involvement, patient may be eligible at the
discretion of the principal investigator.


- Prior corticosteroid therapy allowed

- No prior cytotoxic therapy (other than corticosteroids)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate to the study medications, Alemtuzumab and Rituximab

Outcome Description:

Response rate to the study medications, Alemtuzumab and Rituximab, will be measured at 9 weeks, 18 weeks, and 30 weeks, by physical examination and evaluation of peripheral blood and bone marrow through lab tests.

Outcome Time Frame:

At 9 weeks (during therapy), 18 weeks (at the completion of therapy), and 30 weeks

Safety Issue:


Principal Investigator

Olga Frankfurt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 04H6



Start Date:

March 2005

Completion Date:

December 2015

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia



Northwestern University, Northwestern Medical Faculty FoundationChicago, Illinois  60611-3013